The FDA regulates manufacturers of medical products such as devices, pharmaceuticals, tissue products, and biologics. However, the regulations don’t usually extent to suppliers. Instead, the FDA expects the medical product manufacturer to implement an effective program to qualify and re-qualify suppliers for these regulated industries.
An effective supplier qualification program has some specific elements including determining expectations and requirements, identifying potential suppliers, evaluating them, selecting a supplier, and re-evaluating the selected suppliers. When issues arise, the manufacturer communicates with the supplier and manages corrective action.
The result is a supplier qualification program that address two principle questions:
- Which suppliers are good enough to start doing business with you
- Which suppliers should continue to do business with you
This workshop explains an overarching supplier qualification program that is common to FDA regulated medical product manufacturers. It also provides the details of the various program areas such as devices, pharmaceuticals, etc.
An effective supplier qualification uses tools and techniques. The workshop explains particularly relevant tools such as supplier audits, metrics, scorecards, acceptance verification, and corrective action. These techniques help make the program FDA compliant and robust.
Why You Should Attend:
An effective supplier qualification program can prevent problems and save money. The goal is to ensure that competent suppliers provide products and services correctly and on time. This saves cost and helps you provide good products to your customers. In addition, an effective supplier qualification program meets the regulatory requirements; you will not need to worry about an FDA 483 or a Warning Letter. This workshop provides the information you need to establish and manage an effective program.
Learning Objectives:
Participants learn the elements of an effective supplier qualification program for FDA regulated medical products.
- Define a sustainable supplier qualification program
- Understand how to set expectations and requirements
- Learn how to identify potential suppliers
- Understand methods to evaluate potential supplier’s for their ability to meet your requirements
- Know how to select suppliers based on the evaluation
- Learn the requirements to keep records – a key component for FDA compliance
- Learn sound methods to specify the products and services from suppliers
- Understand how to evaluate received products and services, including statistical techniques
- Learn the techniques to monitor and measure supplier performance
- Understand how to re-evaluate suppliers and keep records
- Learn methods to improve or replace poor performers
- Understand supplier qualification tools including audits and performance evaluation
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Who Will Benefit:
- Purchasing Managers
- Quality Managers
- Supplier Quality Engineers
- Audit Managers
- Compliance Managers
- Law Department Managers
- Session Start Time: 9:00 AM
- Part A – Overview of a Supplier Qualification Program
- Determining expectations and requirements
- Identifying potential suppliers
- Supplier evaluation
- Supplier selection
- Supplier measuring and monitoring
- Supplier re-evaluation
- Supplier communication
- Supplier corrective action
- Part B – Regulatory Framework for Suppliers
- Device regulations
- Tissue product regulations
- Pharmaceutical regulations
- Biologicals regulations
- Commonality and differences
- Guidance documents
- Part C – Requirements and Potential Suppliers
- Defining requirements
- Documenting expectations
- Identifying potential supplier
- Communicating requirements and expectations
- Reviewing the responses
- Part D – Supplier Evaluation and Selection
- Comparing Requirements to Responses
- Using Comparative Tools – The Radar Chart
- Using Comparative Tools – The Cost of Ownership
- Detail Tools – The Onsite Audit
- Detail Tools – Evaluation the Virtual Company
- Detail Tools – Debarment and Similar Issues
- Supplier Selection and Records
- Part E – Placing Purchase Orders
- Defining Contractual Information
- Purchasing Information
- Written Quality Agreements
- Part F – Receiving Product and Services
- Verification
- Statistical Methods – Lot Acceptance Sampling Plans
- Handling nonconformances
- Detail Tools – Requests for Corrective Action
- Part G – Supplier Monitoring and Measuring
- Factors to Consider
- Detail Tools – Classical Supplier Metrics
- Detail Tools – Predictive Supplier Metrics
- Communicating the Results to Management
- Communicating the Results to the Supplier
- Part H – Supplier Re-evaluation
- Identifying Poor Performers
- Retaining Suppliers
- Get Well Programs
- Disqualification of Suppliers
- End of Workshop
Joy McElroy
Principle Consultant at Maynard Consulting Company
Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.
Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.
In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.
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Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).Cancellations and substitutions for In-person Seminars:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Cancellations and Substitutions for Virtual Seminars & Webinars:
Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice. Offers:Related Webinars
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- Building a Vendor Qualification Program for FDA Regulated Industries
- Raw Material Identification, Specifications and Vendor Qualifications
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